Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
NCT ID: NCT00735462
Last Updated: 2011-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2008-08-31
2009-07-31
Brief Summary
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External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks.
Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks
Interventions
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2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
* Negative pregnancy test (for women who are able to become pregnant)
Exclusion Criteria
* Evidence of clinically significant or unstable disease (such as stroke, heart attack)
* Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV types 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
* Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation
12 Years
ALL
No
Sponsors
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Graceway Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Graceway Pharmaceuticals
Principal Investigators
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Jason Wu, MD
Role: STUDY_DIRECTOR
Graceway Pharmaceuticals
Locations
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NEA Clinic
Jonesboro, Arkansas, United States
Northern Claifornia Research
Carmichael, California, United States
California State University - Chico
Chico, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Conant Foundation
San Francisco, California, United States
Downtown Women's Healthcare
Denver, Colorado, United States
Altus Research
Lake Worth, Florida, United States
PMI Health Research Group
Atlanta, Georgia, United States
Atlanta Women's Research Institute
Atlanta, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Howard Brown
Chicago, Illinois, United States
Valley Medical Center
Flint, Michigan, United States
Women's OB/GYN
Saginaw, Michigan, United States
Clayton Research Institute
St Louis, Missouri, United States
Women's Health Research Center
Lawrenceville, New Jersey, United States
Alliance Women's Research
Riverside Park, New Jersey, United States
Southwest Clinical Research
Albuquerque, New Mexico, United States
University Urology Associates
New York, New York, United States
Boro Park ObGyn
New York, New York, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
Rapid Medical Research
Cleveland, Ohio, United States
Complete Healthcare for Women
Columbus, Ohio, United States
Wright State University
Dayton, Ohio, United States
Heartland Health Institute
Tulsa, Oklahoma, United States
Clinical Trials of America
Eugene, Oregon, United States
Westover Heights Clinic
Portland, Oregon, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
Palmetto Clinical Research
Greer, South Carolina, United States
Alpha Clinical Research
Clarksville, Tennessee, United States
Adams Patterson Gynecology and Obstetrics
Memphis, Tennessee, United States
Tennessee Women's Care
Nashville, Tennessee, United States
DiscoveResearch
Bryan, Texas, United States
TMC Life Research
Houston, Texas, United States
West Houston Clinical Research Services
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
The Center for Clinical Studies
Webster, Texas, United States
Utah Clinical Trials
Salt Lake City, Utah, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
CARE-ID
Annandale, Virginia, United States
Tidewater Clinical Reseach
Virginia Beach, Virginia, United States
Independence Family Medicine Clinical Research
Virginia Beach, Virginia, United States
Women's Clinical Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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GW01-0805
Identifier Type: -
Identifier Source: org_study_id
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